Conflict at the Investigator Site, CRO or Vendor. How do I get past it?
Quality Assurances audits of Clinical Investigators, CROs and Vendors are as routine as morning coffee or tea for some of us. But what happens when the situation with the Clinical Investigator, Coordinator, Clinical Staff or Project Manager turns into a difficult one? What responsibilities do we have as Auditors to the Sponsor, the FDA or even to the Investigator? In today’s culturally diverse world it is important that we understand how to deal with different types of people and use appropriate techniques and methods to effectively address critical issues that may lead to or represent regulatory non-compliance. This session will lay the ground work for understanding the situation at hand and it will provide effective tools to add to your auditing tool box for dealing with difficult attitudes or situations that present themselves during a clinical audit. This session will allow the attendee to actively participate in case scenarios and apply the tools presented to better improve their situational management skills in dealing with difficult personalities and situations that may be encountered during an audit.
Setting the Record Straight: Medical Records and Other Source Documents Used in Clinical Trials
The need to demonstrate that research trial data are real and verifiable is critical to supporting the efficacy and safety of an investigational drug or device. Source worksheets, viewed an efficient means of ensuring that all required study-specific data are collected for entry onto the case report forms (CRFs), have become commonplace. Despite convenience, source worksheets may cause the investigator to overlook important information. To be thorough when collecting medical, surgical and medication information during an intake interview, each subject should sign a release for copies of records from his/her personal physician. ‘Logs’ or worksheets limit the amount of information that can be recorded and a study monitor can never be certain that all of the information was transferred to the logs without thoroughly reviewing the sources. Electronic medical records are becoming more commonplace and investigative sites that use these systems must make provisions to allow study monitors, auditors and regulatory agencies access to the study data while preventing access to non-study records. Source documents, including subject questionnaires and diaries, should be initialed or signed, and dated by the individual who records the information and countersigned by the investigator where appropriate. All information critical to the trial must be accurate and available for review and verification must occur at its original source. Study monitors, auditors and regulators need to carefully assess the reliability of this information when evaluating clinical trial data, particularly when substitutions, such as worksheets and photocopies are provided.
Is this Vendor Right for You? Performing Effective Clinical Vendor Qualification Audits
Outsourcing functional components of a clinical program has been a widely accepted practice in the pharmaceutical industry for many years. In addition to the traditional “we do it all” contract research organizations, we now have many vendors offering specialized services, such as EDC software, imaging processing/analyses, statistical analyses, ECG processing/evaluation, Phase 1 Units, and lRBs. Do we need to do anything different when we audit these types of vendors? This session will focus on both core audit criteria and how to make your audit plan and approach vendor-specific to be certain that the audit activity and information collected is comprehensive and meaningful. We will also provide examples of customized qualification audit plans for several types of vendors.
Outsourcing Clinical Audits - Meeting the Standards and Expectations of Diverse Clinical QA Clients
Outsourcing of clinical audits to external Auditors is a frequent necessity of Sponsors to manage the ebbs and tides of clinical development programs and to meet requirements of aggressive Master Quality Plans. What challenges are presented to both consultant Auditors and Sponsors for an effective partnership, successful conduct of Audits and Audit Reports that are acceptable? Various Audit scenarios and case studies involving both contracted independent Consultant Auditors and GCP Consultant Groups will be presented as examples in this session. There will be a recognized sensitivity to the perspectives of both Consultant Auditors who must service diverse Clients, as well as Sponsors who must oversee many different Consultants. Key stumbling blocks that often arise and issues that must be addressed by both parties will be described and discussed, as well as mutual agreements and contingency planning that may be employed to avoid problems. There will be a specific focus on GCP Quality Assurance philosophy as a basis for building sound working relationships and a highlight of critical communication, cooperative planning, workflow and techniques to ensure that comprehensive Audits are performed and quality Audit Reports are received by Sponsors to meet expectations and contractual requirements.
New Approaches to Clinical Investigator GCP Training
For years Clinical Investigator GCP Training has been relegated to a 30 minute presentation at the Investigator Meeting, reviewing the FDA Form 1572 and associated requirements. Is this really enough to ensure adequate Investigator GCP knowledge for the conduct of a clinical study? What are the roles and responsibilities of the Investigator and do they know and understand them? The lack of oversight and supervision of the clinical trial by the Investigator has become one of the top five (5) non-compliance observations reflected in FDA Warning Letters. What are you able to do about it? This session will provide insight into current issues and the implications associated with the lack of Investigator training. It will explore “customized” options that your company can employ to implement a more efficient and effective training program for your Clinical Investigators. Examples of effective tools, techniques and methods to enhance their GCP Training will be presented. Active participation of attendees in case scenarios and template development will enable the application of tools presented in this session to their current company approach to Clinical Investigator training. Outcome goals include improved effectiveness, efficiency, controlled costs and in the long-term improvement in Investigator GCP compliance.
Process Mapping: A Sound Base for Clinical Research SOP Development
One of the most time consuming and inefficient activities in Clinical Research operations is the development of Standard Operating Procedures (SOPs). Every firm has their own approach in developing SOPs, but many have not mastered an effective and efficient way to write and update SOPs. So what is the solution? Process Mapping. Applied appropriately in a model that combines quality, regulatory considerations and business efficiencies, Process Mapping is a method of documenting a standardized process that can be easily converted into an SOP. Process Mapping exposes adjacent departments and functions to each other in an open forum, and results in a practical, useable product. This presentation will discuss how process mapping can be used as a basis for SOP development that will decrease the time needed for authoring and reviewing, breaks down “walls” between departments and functions, removes "silos" and provides a method for “simplifying” the SOP content into a large-scale visual format. Benefits and challenges of process mapping will be presented and attendees will walk away with practical steps for incorporating process mapping into their firm’s SOP development process.
Completing the actions in a CAPA Program for GxP Compliance – An influential and critical role for QA
Corrective and Preventative Action (CAPA) Programme activities are integral to the strength of Risk Management and Quality Systems governing and supporting GXP compliance in drug and device development. A good CAPA Programme requires comprehensive planning and strategies to ensure the adequacy of resolution and enforcement toward compliance goals. Effective CAPA Plans must include practical implementation tactics for success in facilitation of problems resolution and the design of preventative action initiatives. Well recognized and understood in the GMP and GLP arenas, CAPA in the GCP environment has become an accepted concept and more common application. QA has a major opportunity to be heavily involved and influence the correction of problems and contribute to preventative actions as a facilitator and enforcer. This presentation will discuss actions in a CAPA Programme that will support GXP compliance, with a specific emphasis on the important role of QA. Representative CAPA “Case Studies” for GMP, GLP and GCP will be presented, with respective roles and suggested actions by QA.
Building An Effective Clinical QA Unit With Internal And External Resources
QA and QC activities are an integral part of any clinical program and require a staff of adequate number and expertise to be effective. For a small company, the clinical quality assurance unit is likely to be understaffed or possibly even nonexistent. Large pharmaceutical companies have QA units that cycle through growth and downsizing periods. Depending on where they are in this cycle, the QA unit might be out of synch with the demands of current clinical activities. For both of these situations, QA activities can be completely outsourced. This scenario, while convenient, is not the most cost effective means of addressing QA needs over the long-term. A more effective and efficient model of a clinical QA unit is the integration of both internal and external resources. The internal component is essential for ensuring adequate management of the clinical QA program, establishing goals that meet corporate objectives, and facilitating ongoing communication with senior management. The external component is determined by the short-term needs of the company at any given time so the number and expertise of these resources can vary as needed.
Clinical Trial Master Files – Remedies to QA Observations
The conduct of Clinical Research studies includes extensive and detailed activities related to the collection, organization and maintenance of general study files and investigator-specific documents. Unfortunately it appears that industry-wide efforts related to both initial and ongoing quality control of individual documents as well as overall file completeness and organization remain deficient and frequently result in major findings during quality assurance audits. Too often the files for a clinical study are left as a final activity ending in crisis management clean-up, organization and collection of missing documents. What are the remedies to ensure the integrity of Clinical Trial Master Files? Our experience has shown that practical and logical planning, diligent quality control procedures and clearly defined document processing workflow will contribute to a solution. The appropriate application of new technologies for document management, including document tagging, scanning and electronic filing techniques further supports the adequate and efficient management of study files. This presentation will discuss important quality issues, study the challenges of document management, and provide suggested mechanisms and initiatives for quality management of Clinical Trial Master Files.